This Funding Opportunity Announcement (FOA) issued by
NIEHS and EPA encourages grant applications to support a transdisciplinary
program of basic and applied research to examine the effects of environmental
factors on children’s health and well-being. Research conducted through the
Centers should include substantive areas of science in children’s health
while incorporating innovative technologies and approaches and links to the
environment. The revised program encourages strong links between disciplines
in the basic, applied, clinical and public health sciences to prevent disease
and promote health in all children.

Key Dates

Posted Date

April 5, 2012

Letter of Intent Due Date

June 17, 2012

Application Due Date(s)

July 17, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

November 2012

Advisory Council Review

January 2013

Earliest Start Date(s)

April 2013

Expiration Date

July 18, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

NIEHS and EPA created the jointly funded Centers for
Children's Environmental Health and Disease Prevention Research Program
(Children's Centers) in 1998. The guiding principle for this program is to
ensure the healthy growth and development of children by protecting them from
potential environmental threats and promoting their well-being in the
communities where they live, learn and play. The program includes
community-based projects, that incorporate both applied and basic science
research approaches, and are facilitated by community outreach and translation
components. These Children's Centers use multidisciplinary approaches to look
at the consequences of early life (pregnancy and early childhood) exposures to
environmental chemicals on the health of children and adolescents through a
variety of transdisciplinary research programs.

By combining research and outreach, the Children's Centers
provide the foundation for a broad base of research on children’s environmental
health. They have developed a national network of researchers, health care
professionals and advocacy and parents groups to address a range of health
outcomes that may result from environmental exposures and unhealthy
environments. These could include impairments in overall growth, developmental
challenges from adverse birth outcomes which may result in increased risk of
chronic diseases later in life (e.g., childhood cancer and metabolic
disorders), impairments in nervous system development which may lead to
behavioral and learning deficits, altered structure and function of the
respiratory system, associated immune responses, and endocrine disruption that
may result in systemic disorders.

To protect the environmental health and well-being of
children in a sustainable manner, a holistic approach to a child’s environment
needs to be considered. This includes factors that may impact a child’s health
and well-being including: a child’s developmental stage, physiology, and
activities and behaviors; and environmental, economic, and societal (both
family and community) factors (both chemical and non-chemical stressors).

Purpose

NIEHS and EPA will continue to support and facilitate
integrated fundamental, clinical, laboratory, and public health science to:
(1) identify the positive and/or negative influences of environmental exposures
and changing environments on normal physiological function of organs and
systems of the fetus/child during gestation/childhood/adolescence; (2)
determine the mechanisms of vulnerability to environmental stressors of the
fetus and young child at all stages of early development; and (3) consider
children’s health from a holistic perspective where the impact of complex
environmental exposures may be exacerbated by non-chemical, social, life-style
and economic stressors encountered in community settings. Chemical stressors
may be considered as single chemicals, or as mixtures and aggregates as may be
found in consumer products used by children and environments frequented by
children. Non-chemical stressors include modifying factors such as diet and
nutrition, physical activity including time spent in various microenvironments,
psychosocial factors, and the design of the built environment (e.g., settings:
home, school, play areas) from birth through young adulthood. Non-chemical
stressors, social and cultural factors, and settings cannot be considered
alone, but they can be included as modifier variables to the primary
environmental stressor(s).

NIEHS and the EPA recognize that healthy children are the
foundation of sustainable communities. Therefore, in addition to considering
the health impacts of children’s environments, the Children’s Centers Program
is evolving to incorporate principles of sustainability as articulated in the
recent NAS report on Sustainability (available at: http://www.nap.edu/catalog.php?record_id=13152).

Under this FOA, NIEHS and EPA plan to provide additional
funds to support an optional fourth research project to encourage partnerships
between the applicant organization and institutions that are not highly funded
for research and development capacity. NIEHS and EPA encourage partnerships
with institutions that have traditionally received less than $35 million/year
in federal funding for research and development, including institutions that
have unique missions and have historically provided services to health
disparity populations including minority, low income and tribal communities.
These institutions, including Historically Black Colleges and Universities
(HBCUs), Hispanic Serving Institutions (HSIs), Tribal Colleges and Universities
(TCUs) and Asian American Native American Pacific Islanders Serving
Institutions (AANAPISIs), have demonstrated access to these populations, which
have not historically fully participated in children’s environmental health research.

This “additional” funding must stay within the confines of
the total award budget allowed per grant described in Section II. EPA and
NIEHS strongly encourage applications from and partnerships with faculty at
colleges and universities that have received less than $35 million/year in
federal funding for research and development as listed in the National Science
Foundation's publication "Federal Science and Engineering Support to
Universities, Colleges, and Nonprofit Institutions: FY 2007," Table 12,
column 2 (NSF 2007), available at http://www.nsf.gov/statistics/nsf12301/pdf/tab12.pdf.
Additional information is provided below.

Research Objectives, Expected Outputs and Outcomes

NIEHS and EPA have developed a joint program with multiple
opportunities to enhance the research in children’s environmental health to
meet each Agency’s mission by filling identified research gaps. This Funding
Opportunity Announcement (FOA) is designed to encourage applications from
strong transdisciplinary research teams proposing an integrated multi-project
approach and a well-developed program of cutting-edge research.

The objectives are to (1) capitalize on the research
findings and resources from epidemiological and clinical studies of prospective
parents, pregnant women and children; (2) enhance the application of novel
findings and approaches in areas of basic or mechanistic research e.g.,
imaging, epigenetics and comparative biology to developmental human studies;
(3) develop and apply new or improved biomarkers, environmental measurements
(indoors and outdoors), and exposure factors and models to best characterize
exposure, potential health effects at various lifestages, and predict
longer-term clinical consequences; (4) train new investigators to address
emerging issues in children’s environmental health with state of the art tools and
methodologies; and (5) ensure active participation of identified stakeholders
and the broader community in the research process and translation and
application of research findings.

Outputs (results) expected from the research funded under
this FOA may include:

Original peer-reviewed articles and synthesis
reports, some of which could inform children’s health decision makers (parents,
medical care providers, local governance, policy makers)

Analysis of complex biological, environmental and social
datasets in order to provide insight into the interaction of these domains and
their influence on disease occurrence or prevention, success of mitigation
strategies, and public health interventions.

The development and application of multimedia measurements,
databases, exposure factors, models, and biomarkers of exposure,
susceptibility, and/or effects for use in interpreting children’s health risks
and prevention strategies.

The development and application of novel, low
subject burden tools and methods to determine exposure risk from multiple
sources and routes, and/or better predict and prevent health outcomes with
greater specificity.

Expected outcomes (potential benefits) of the proposed
research include:

The use of both (1) developed tools and methods for
more rigorous analyses of children’s health risks and (2) the use of basic
science and/or population-based research findings to inform decision-making to
reduce or eliminate potentially harmful environmental exposures to children and
promote children’s health in community settings.

Increasing the number of experts trained in
cross-disciplinary fields in children’s environmental health based on the
latest scientific discoveries.

Active engagement of a community and other stakeholders
in basic and/or population-based research.

Translation and sharing of research findings with
health care professionals and other care providers to promote and improve
children’s health.

Research Approaches

The types of research approaches that are encouraged under
this FOA include but are not limited to the following:

Testing new research hypotheses probing
environmental linkages to childhood diseases and disorders using existing human
studies, registries, environmental samples (both stored and newly collected)
and biospecimens. The request to establish a new cohort of pregnant mothers or
children is discouraged unless compelling supportive evidence warrants the
need. Note: To receive EPA funding any new cohort will have to comply with the
requirements identified in section IV.

The integration of multiple study populations or
consortia to pool common data elements or to conduct comparable analyses to
improve the ability to test the effect(s) of environmental exposures on
diseases, and/or improve understanding of the complex interplay between gene
variants and multiple exposures at multiple dose levels for complex disease
risk.

Basic mechanistic laboratory studies utilizing in
vitro, in vivo, and/or in silico models of molecular, cellular, tissue and
organism responses to developmental perturbation by environmental agents, as
one project component, if justified in order to test hypotheses about the
environment-disease linkage under study in the overall project.

Exposure sciences and development and evaluation of
targeted prevention and intervention efforts.

- Use of predictive models to test new research
hypotheses using available data and comparing the estimates to available data.

Enhanced involvement of impacted communities in the
research process. Community-Based Participatory Research (CBPR)
methods/approaches are encouraged. This is a process of scientific inquiry
such that community members, persons affected by the health condition,
disability or issue under study, or other key stakeholders in the community
have the opportunity to be full participants in each phase of the work (from
conception to design, implementation, analysis, interpretation, conclusions,
and communication of results). CBPR is characterized by substantial community
input in the development of the project.

Research that could lead to better understanding of
environmental health issues of children living in rural communities.

Interdisciplinary approaches to children’s health
including the influence of social factors and the design of the built
environment.

Applicants must study an
environmental agent/chemical/stressor to which there is human exposure and the
potential for an in utero exposure. This includes any endocrine active
chemical(s) or organic solvents, particulate matter (PM), pesticides, phytochemicals
or metals. Non-chemical stressors (e.g., nutrition), social, and cultural
factors cannot be considered alone, but applicants are encouraged to include
them as secondary or modifier variables to the primary environmental stressor.
The Children’s Centers are required to translate and apply their research
findings into information for the affected communities, general public,
policy-makers and health care professionals with the ultimate goal of
protecting children."

Research Topics of Interest

Research Topics of interest that applications may focus on
under this FOA include, but are not limited to, those listed below. In all
cases applicants should show how the application will significantly advance the
field rather than confirm or refine earlier findings or models.

The effects of in utero and/or perinatal exposures to
environmental agents (chemical and/or biological) and the role they play by
lifestage in biological changes associated with adverse childhood health
outcomes.

Use of emerging technologies or approaches to improve exposure
and dose estimates to reduce exposures and improve children’s health in
community settings, incorporating more direct measures and modeling of exposure
and their correlation with biological processes and child health outcomes.

Identification and characterization of mechanisms and pathways of
exposure, including exposure factors (such as soil and dust ingestion) and
factors that may increase vulnerability or protection to the fetus or child
exposed to specific environmental agents.

Assess the impact of perinatal exposures on the composition
and/or function of the microbiome and how this contributes to childhood disease.

Characterization of environmental exposures (chemical and
biologic), and related outcomes, in settings of greatest importance for
children’s exposures (such as homes, child care centers, schools, playgrounds
and/or workplaces) and development of strategies to reduce or prevent adverse
exposures in those settings. (For consistency, applicants are encouraged to use
the lifestage/age grouping guidance from the EPA Risk Assessment Forum,
available at http://www.epa.gov/raf/publications/pdfs/AGEGROUPS.PDF.)

Identification of childhood age groups/lifestages that might be
particularly susceptible to certain environmental health concerns such as those
related to dietary intake, air, soil/dust, food, water, and land use.

Development of appropriate biomarkers predictive of alteration in
development to design and evaluate targeted prevention and intervention efforts
and to be used to test hypotheses of early environmental exposures influence on
development of disease or disorders.

Identification of potential mechanisms (including genetic and
epigenetic) that may influence susceptibility to environmental exposures and
contribute to disease onset or course in children, and the role of epigenetics
in gene-environment interaction.

Development of studies that focus on diseases or disorders where
an environmental exposure is suspected but less well established such as
autoimmune disorders, childhood cancers, adverse birth outcomes,
neuropsychiatric and neurological disorders.

Improved understanding of interactions between environmental
chemicals and psychosocial or socioeconomic factors that may increase the
vulnerability of children and/or adolescents with the goal of reducing and
preventing health disparities.

Evaluation of environmental health concerns for children in
population groups not well represented in the published scientific literature
such as Asian and Pacific Islander and Native American children, as well as
children living in rural areas.

Required Components

Each Children's Center will propose an overall scientific
research theme and plan related to the role of the environment (defined
broadly) in the etiology and prevention of children’s adverse health outcomes
that is responsive to the objectives of the NIEHS and EPA Children’s Centers
Program and responsive to the mission of each Agency.

The application must contain a minimum of three (3) unique
but integrated research projects related to the Center’s theme and three (3)
essential elements:

Community Engagement (CE) including a Community Outreach and Translation
Core (COTC).

Career development of new, junior faculty-level investigators in
the field of environmental health science.

Each Children's Center must also include an Administrative
Core to provide oversight, coordination and integration of Center activities as
well as a Community Outreach and Translation Core (COTC).

Each Children's Center is expected to include a data sharing
plan to facilitate data sharing with other Children's Centers, federal
researchers, the public, and other key stakeholders.

Applications not containing at least three projects, the
three essential elements referenced above, an Administrative Core will be
considered non-responsive and will not be reviewed.

Detailed Description of Required Components in the Application

A. Applicants must propose an overall research theme and
plan that are responsive to the objectives of the NIEHS and EPA Children’s
Centers Program. The central scientific theme should be related to the role of
the environment (defined broadly) in the etiology and prevention of adverse
health outcomes in children. The application must contain three (3) essential
elements (outlined below), a minimum of three (3) research projects, an
Administrative Core. In addition, a data sharing planis expected to be
included. A fourth research project is optional (see the following sub-section
for details).

Each application will require three unique but integrated
research projects (equivalent to an R01) related to the Center’s theme with an
option for a fourth project described below.

Fourth Research Project (optional)

Applicants may propose an optional fourth research project
in children’s environmental health designed to provide an opportunity to expand
the research capabilities of institutions that are traditionally not highly
funded for research and development capacity and for institutions that have
unique missions and have historically provided services to health disparity
populations including minority, low income and tribal communities. To be
eligible for this optional project, applicants are strongly encouraged to
partner with institutions receiving less than $35 million/year in federal
funding for research and development as listed in the National Science
Foundation's publication "Federal Science and Engineering Support to
Universities, Colleges, and Nonprofit Institutions: FY 2007," Table 12,
column 2 at http://www.nsf.gov/statistics/nsf12301/pdf/tab12.pdf.
More information on potentially eligible institutions can be found at EPA’s web
site http://www.epa.gov/osbp/mai_program.htm.
Ideally this project would enhance the research capabilities of those colleges
and universities receiving less than $35 million/year in federal research and
development funding as listed in the NSF 2007 publication; train new
investigators in emerging issues in children’s environmental health with state
of the art tools and methodologies; and provide career development
opportunities. A successful application will demonstrate meaningful and active
participation, as well as a collaborative research process involving both
institutions. Applicants should demonstrate how the proposed research in this
project will be integrated with the other three research projects and identify
how the project will significantly advance the field in protecting children’s
environmental health.

B. To accomplish the research objectives of the program,
each Children's Center will be required to incorporate three (3) essential
elements into the proposed program. The essential elements are:

(1) Community engagement (CE) including a Community Outreach
and Translation Core (COTC). Each Center must demonstrate meaningful and
active participation of relevant stakeholders that may have concerns about
children’s environmental health and/or environmental exposures under
investigation and must include a COTC. The COTC would develop, implement and
evaluate strategies to translate and apply the scientific findings of the
Center into information for use by the public, policy- makers, and clinical
professionals to protect children’s health. The COTC may include a variety of
mechanisms for community engagement for one or more of the projects. Examples
include (1) a Community-Based Participatory Research (CBPR) plan demonstrating
the collaborative process of research involving both researchers and community
representatives. The CPBR plan would include consultation with key stakeholder
groups in order to consider their views in the design of research projects and
to enhance the translation of findings to these key audiences; and/or (2)
community advisory boards.

(2) Engagement of at least one Health Specialist directly
relevant to the Center’s theme (e.g., pediatric health specialist, clinical
expert in the disease area under investigation) This individual must be an
active researcher who is qualified to assist with coordination and integration
of the scientific projects and who will help ensure that the science under
investigation will translate to clinical practice and/or have a positive impact
on public health. This person may come from any discipline that traditionally
has direct contact with young children in a treatment-based environment,
however, the expertise should be suited to the Center’s scientific theme. This
individual should be distinct from the Center Program Director. This function
can be supported as part of the Administrative Core at no less than 10%
effort. The Health Specialist may serve as a project
leader/co-leader/co-investigator with additional percent effort.

(3) Career Development. In order to foster the next
generation of creative new scientists in children’s environmental health,
Center Program Directors are required to support the research career
development of new, junior faculty-level investigators within the structure of
the Children’s Center. We encourage applicants to consider inclusion of an early
stage investigator (including investigators from institutions that have not
received federal funding for research and development in excess of $35
million/year as listed in the NSF 2007 publication above) as part of the Center’s
career development plan. One individual should be designated for Faculty
Development in the application. This person will be expected to devote a
minimum of 3 person-months o the award and have a long-term commitment to
research in the environmental health sciences. The Faculty Development
Investigator (FDI) may hold either a health professional doctorate (M.D., D.O,
Pharm. D., doctoral degree in nursing, or other equivalent degree) or a
research doctoral degree (Ph.D., or equivalent), should have fewer than eight
years of postdoctoral experience (excluding clinical training years) at the
time the application is submitted, and should have demonstrated outstanding
abilities in basic, clinical or population based research. Designated Faculty
Development Investigators must meet the NIH definition of New Investigator, http://grants.nih.gov/grants/new_investigators/resources.htm#definition.
The Program Directormust include a description of the career development
proposed to be undertaken by the Faculty Development Investigator and provide a
letter of recommendation for the designee. A letter from the FDI candidate
outlining his/her career goals should also be included in the application. The
Faculty Development plan should be included as part of the Administrative
Core If the candidate is unknown at time of submission, a general plan to
recruit the FDI is required.

C: CORE(S):

1. Administrative CORE (required): Each Center must include
an Administrative Core unit to provide oversight, coordination, and integration
of Center activities. Individuals in senior leadership positions should provide
intellectual, administrative, and scientific leadership for the Center and are
critical to its overall effectiveness and evolution. These individuals should
be in place and committed to a defined percent effort. Unless otherwise performed
by the COTC, the Administrative Core should coordinate community engagement and
facilitate meaningful exchange between Center investigators, the community, and
stakeholders.

An External Advisory Committee (EAC) to the Center Director
should be established and managed as part of the Administrative Core. The
function of the EAC is to assist in evaluating the merit, value and ongoing
progress of each research project and the relevance and importance of
individual organizational elements to accomplish the overall goals of the
Center. This group should consist of three to five members having expertise
appropriate for the Center's research focus, plus one representative from a
community group. Representation from a state or local health department is
also encouraged. At least two-thirds (67 percent) of the Committee members
should be from outside the grantee institution. The EAC is required to meet at
least once annually and NIEHS and EPA staff should be notified of the meeting
and invited to attend. A brief report describing the recommendations of the EAC
should be provided as part of the annual progress report. Names of potential
EAC members should not be solicited or submitted in the application. Please
only submit a description of proposed protocols and planned committee by
representation and area of expertise. If awarded, you will be asked to provide
an identifiable list of membership to the EAC for review by the funding
agencies.

2. Community Outreach and Translation Core (COTC) (required):
The purpose of this Core is to develop, demonstrate and evaluate strategies to
translate and apply the scientific findings of the Center into information for
the public, policymakers, and clinical professionals to use to protect the
health of children. This must include personnel from one or more of the
following areas: health educators, nurses, members of community or faith-based
organizations, members of organizations which advocate for research and
services pertaining to children's health, members of professional societies of
health care professionals, and state and local health departments or medical
service organizations. Examples of activities considered responsive are the
creation of training materials for health professions, development of novel
strategies for dissemination of research findings to the broad audience of
stakeholders, and assessment of community understanding of research results and
plans for action. Community-Based Participatory Research (CBPR)
methods/approaches are encouraged. This is a process of scientific inquiry
such that community members, persons affected by the health condition,
disability or issue under study, or other key stakeholders in the community
have the opportunity to be full participants in each phase of the work (from
conception to design, implementation, analysis, interpretation, conclusions,
and communication of results). CBPR is characterized by substantial community
input in the development of the project.

NIEHS has created a database management system to archive
and disseminate outreach materials developed within an environmental research
portfolio. There is an expectation that the COTCs will use this repository for
the Center management of materials development with the intention for broader
outreach to the environmental health research community, stake holders and
public. NIEHS will facilitate gaining access to this database and NIEHS will
be responsible to manage and maintain the repository and to facilitate outreach
efforts.

3. Other CORES (as needed): Each Center is encouraged to
make use of existing Core services and resources available through their
institution. New Cores should be proposed in the application only if they are
not available through existing services or facilities. Each new Core proposed
must serve at least two research projects and provide a technique, service, or
instrumentation that will enhance ongoing research efforts. Examples include
animal resources, cell/tissue culture, pathology, public and environmental
health, biostatistics, molecular biology, neuropsychology, neuroimaging,
analytical chemistry, exposure assessment, genotyping, and re-sequencing.

To be eligible for EPA funding consideration, a project’s
focus is to consist of activities within the statutory terms of EPA’s financial
assistance authorities; specifically, the statute(s) listed below (see section
VIII). Generally, a project must address the causes, effects, extent,
prevention, reduction, and elimination of air pollution, water pollution,
solid/hazardous waste pollution, toxic substances control, or pesticide control
depending on which statute(s) is listed above. These activities should relate
to the gathering or transferring of information or advancing the state of
knowledge. Applications should emphasize this “learning” concept, as opposed
to “fixing” an environmental problem via a well-established method. Applications
relating to other topics which are sometimes included within the term
“environment” such as recreation, conservation, restoration, protection of
wildlife habitats, etc., must describe the relationship of these topics to the
statutorily required purpose of pollution prevention and/or control.

EPA has specific application guidance for research that
involves human subjects. Please see the last paragraph of this section for
further information pertaining to the need of this guidance, and Section IV,
“EPA Human Subjects Research Statement (HSRS)” of this FOA for specific
instructions.

Multiple Investigator applications may be submitted. If you
choose to submit a Multiple Program Director(s)/Principal Investigator(s)
application, you must follow the specific instructions provided in Sections IV.
and V. of this FOA. For further information, please see the EPA Implementation
Plan for Policy on Multiple Program Director(s)/Principal Investigator(s) (http://rbm.nih.gov/toolkit.htm).

These awards may involve the collection of “Geospatial
Information,” which includes information that identifies the geographic
location and characteristics of natural or constructed features or boundaries
on the Earth or applications, tools, and hardware associated with the
generation, maintenance, or distribution of such information. This information
may be derived from, among other things, a Geographic Positioning System (GPS),
remote sensing, mapping, charting, and surveying technologies, or statistical
data.

For human subjects research applications, there are many
scientific and ethical considerations that must be addressed by the study
sponsor and research team, including, but not limited to, those related to
recruitment, retention, participant compensation, third-party issues,
researcher-participant interactions, researcher-community interactions,
communications, interventions, and education. All such research must comply with
the requirements of the Common Rule (40 CFR Part 26), and any human
observational exposure studies must also adhere to the principles set forth in
the Scientific and Ethical Approaches for Observational Exposure Studies
(SEAOES) (EPA/600/R-08/062) (http://www.epa.gov/nerl/sots/SEAOES_doc20080707.pdf)
document. SEAOES, which was published by researchers in EPA and which
discusses the principles for the ethical conduct of human research studies,
serves as a resource for applicants interested in applying under this FOA.
References to “SEAOES Principles” in this FOArefers, in general, to the issues
of interest in conducting human subjects research studies that maintain the
highest scientific and ethical standards and safety during the conduct of these
studies. All applications must include a Human Subjects Research Statement
(HSRS; described in Section IV) and if the project involves human subjects
research, it will be subject to an additional level of review prior to funding
decisions being made as described in Section V of this FOA.

Section II.
Award Information

Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER
Glossary and the PHS398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

NIEHS and EPA intend to fund an estimate of 7 awards,
corresponding to a total of approximately $12 million per year combined from
both agencies, including direct and Facilities and Administrative (F&A)
costs, annually for 5 years beginning in fiscal year 2013. Future year
amounts will depend on annual appropriations.

EPA and NIEHS plan to concurrently fund Centers with
funding shared by EPA and NIEHS and managed by both EPA and NIEHS. If a
Center is concurrently funded, the Center will be supported by two awards:
one which provides the EPA portion of the budget, and a companion award which
provides the NIEHS portion of the budget. There may be an opportunity
for a Center to be funded by only one agency related to mission priorities or
program needs, in which case the Center will receive one award by the funding
agency.

In appropriate circumstances, EPA and NIEHS reserve the
right to partially fund applications by funding discrete portions or phases
of proposed projects. If EPA and NIEHS decide to partially fund a
application, they will do so in a manner that does not prejudice any
applicants or affect the basis upon which the application, or portion
thereof, was evaluated and selected for award, and therefore maintains the
integrity of the competition and selection process.

Both NIEHS and EPA reserve the right to reject all
applications and make no awards, or make fewer awards than anticipated, or to
make additional awards consistent with the policies of the Agencies, if
additional funding becomes available after the original selections are made.
Any additional selections for awards will be made no later than six months
after the original selection decisions.

Award Budget

For each Center, application budgets are limited to $1
million per year direct costs for up to 5 years or up to $1.2 million per
year direct costs for up to five years if the optional Project 4 is included.
Budgets need to reflect actual needs of the proposed projects. Funding in
subsequent years is contingent upon satisfactory progress during the
preceding year and availability of funds.

Award Project Period

The total project period for an application submitted in
response to this funding opportunity may not exceed 5 years.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Note: Nonprofit organizations described in Section 501(c)
(4) of the Internal Revenue Code that lobby are not eligible to apply for EPA
funding. Profit-making firms are also not eligible to receive grants from EPA
under this program.

National laboratories funded by Federal Agencies
(Federally-Funded Research and Development Centers, “FFRDCs”) may not apply.
FFRDC employees may cooperate or collaborate with eligible applicants within
the limits imposed by applicable legislation and regulations. They may
participate in planning, conducting, and analyzing the research directed by the
applicant, but may not direct projects on behalf of the applicant
organization. The institution, organization, or governance receiving the award
may provide funds through its assistance agreement from the EPA to an FFRDC for
research personnel, supplies, equipment, and other expenses directly related to
the research. However, salaries for permanent FFRDC employees may not be
provided through this mechanism.

Federal Agencies may not
apply. Federal employees are not eligible to serve in a principal leadership
role on an assistance agreement, and may not receive salaries or augment their
Agency’s appropriations in other ways through awards made under this program.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH
Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed. Resubmission applications will not be accepted.

Section
IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the PHS398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All page limitations described in the PHS398 Application
Guide and the Table of
Page Limits must be followed, with the following requirements:

Overview of the Program Project: 12 pages

Research Project Descriptions:

Research Project Cover Page: 1 page

Research Project Summary: 1 page

Research Project Specific Aims: 1 page

Research Strategy: 12 pages

Core Descriptions:

Core Unit Cover Page: 1 page

Core Unit Summary: 1 page

Core Unit Specific Aims: 1 page

Core Unit Structure, Administration &
Services: 6 pages

Description

Follow instructions in the PHS 398 Application Guide, and
note the following additional instructions.

The program project grant application should be structured
as a series of separate but interrelated projects . State the proposed
program’s broad, long-term objectives, specific aims, and the significance to
the mission of NIEHS. Define the relevance of each proposed project and shared
resource core to the overall theme and goals of the program.

Detailed Budget for Initial
Budget Period

Follow instructions in the PHS 398 Application Guide, and
note the following additional instructions.

Use PHS-398 Form Page, "DETAILED BUDGET FOR INITIAL
BUDGET PERIOD," to present the total budget for all requested support for
the first year. For each category, such as "Personnel,"
"Equipment," etc., give the amount requested for each Research Project
component and each Core unit, with subtotals.

If consortium arrangements involving other institutions or
organizations are anticipated, include total (direct and indirect) costs
associated with such third-party participation in the Consortium/Contractual
Costs category. Costs for purchased services should be itemized under the
"Other Expenses" category.

Budget for Entire Proposed Period of Support

Follow instructions in the PHS 398 Application Guide, and
note the following additional instructions.

Use PHS-398 Form Page, "BUDGET FOR ENTIRE PROPOSED
PROJECT PERIOD," to prepare a budget, by category, that provides totals
for each year of requested support. Requests for any increases in succeeding
years must be justified in the individual Research Project component and Core unit
budgets.

Budgets for Individual Research Project Components and Core
Components

Prepare “Detailed Budget for Initial Budget Period” for each
component

Prepare “Budget for Entire Proposed Period of Support” for
each component

Budget Justifications and Explanations

Describe the specific functions of all key personnel,
consultants, collaborators, and support staff. For all years, explain and
justify any unusual items such as major equipment or alterations and
renovations.

Biographical Sketch

Follow instructions in the PHS 398 Application Guide, and
note the following additional instructions.

Biographical sketches are required for all key personnel
participating in the Research Project components and Core units. Compile all
biographical sketches starting with the overall program project leader followed
by all other investigators, including the individual project/ core leaders, in
alphabetical order. Do not repeat biographical sketches in the individual
research projects or shared resources cores.

Resources

Follow instructions in the PHS 398 Application Guide, and
note the following additional instructions.

Complete the "Resources" page of PHS-398 for the
overall project. Briefly describe the features of the institutional environment
that are or would be relevant to the effective implementation of the proposed
program. As appropriate, describe available resources, such as clinical and
laboratory facilities, participating and affiliated units, patient populations,
geographical distribution of space and personnel, and consultative resources.

Project Overview

Each P01 program project application must include a minimum
of three individual (albeit connected) research projects each of which is
pertinent to the central goal of the program. If support of core resources is
requested, a separate component describing and justifying these should be
included.

Research Projects

The Research Projects should include:

Cover page.
Project Summary
Project Specific Aims
An overall research strategy section for the
project
Any justification for human and animal
experimentation.

Each individual project of a program project grant should
represent both a separate and an interdependent research effort. Each research
project should be prepared according to the application guide instructions. The
overall format and page limits for an R01 application apply to each of the
component projects. The special benefits associated with being part of the
program project must also be addressed. Do not repeat the individual budget
pages and biosketches.

Instead of the standard PHS 398 face page for each project,
create a cover page for the project that lists the project name and the name of
the project director.

Specific Aims

Specific aims should be built around serving the goals of
the program project.

Research Strategy

Approach. The special benefits associated with being part of the program
project and the relationship of this project to the other projects and cores
should be addressed.

Core Descriptions -- Administrative Core

A successful CEHC application
will include a well-integrated project plan. Within the Administrative Core,
the specific administrative and organizational structure that is needed to
support the research and the synergies enabled by the Center needed to be clearly
articulated. CEHC projects will be multidisciplinary and interdisciplinary and
will draw from a variety of resources. Thus, a well thought out and carefully
described organizational structure will be required.

A narrative description
should be provided that includes the planning and coordination of research
activities; the integration of cross-disciplinary research; the tracking of
progress towards Center outputs and outcomes, the oversight of fiscal and
resource management; and the maintenance of ongoing communication with NIEHS
and EPA. Indicate who will be responsible for each of these activities.
Describe the role(s) of advisory groups and consultants.

Describe how the
Administrative Core will coordinate the research activities with existing training
resources, activities or programs at the institution. No specific funds should
be used to develop new training programs or to directly support existing
training programs, however, a listing of available training resources should be
provided. A plan for tracking the impact of CEHC on investigator training
should be described.

Develop and describe a career
development plan with the institution

Describe how the
Administrative Core will coordinate meetings of CEHC investigators with
investigators from other CEHCs including active participation in planning the
annual Children's Centers meeting.

The applicant should budget
travel funds sufficient for attendance of the Center Director and Project and
Core leaders at an annual meeting, a one and one-half day meeting at the NIEHS
in Research Triangle Park, NC or at the US EPA in Research Triangle Park, NC or
Washington DC.

Describe the Children's
Health Specialist and their expertise and role in the overall integration of
the proposed projects and the support of the overall translation central theme
of the Center.

Facility/Service Cores

Describe the function of the
core as a resource to the program. This section must clearly present the
facilities, techniques, and professional skills that the core will provide. As
justification for the core, briefly indicate the specific Research Projects
that will use the resources of the core. A Research Support Core is principally
designed as a service or resource component; it would be highly unusual to
include research in a core (a possible exception would be methodology
development). Please contact the NIEHS program staff if you require guidance on
this issue.

Describe the role of the core
as a resource to the program as a whole. Discuss ways in which these centralized
services will produce an economy of effort and/or savings in overall costs
compared to their inclusion as part of each project in the program. To aid in
the review of your application it is recommended that you prepare in tabular
form information concerning the research projects that each facility core unit
would serve and the proportion of the cost of the facility core unit associated
with each research project involved.

NOTE: An Applicant is not
required to include facility cores in their CEHC.

Community Outreach and
Translation Core

A successful COTC should
describe a plan to collect, integrate and disseminate research findings and
Centers activities for the public, policy makers, and clinical professionals to
use to protect the health of children.

Describe the membership of
the COTC and types of expertise to be recruited to enhance effective
communication strategies. Describe the type of innovative methods that may be
used to enhance COTC activities including ways of interacting with stakeholders
or identified end-users of materials.

Describe plans of how the
COTC investigators will be able to access the effectiveness of their developed
products and whenever possible.

Describe how the COTC will
interact with Center investigators and the Administrative Core to develop
materials and assist with the goals of the COTC.

Describe how the COTC will
develop, enhance, and ensure a productive working relationship between the
community and Children’s Center researchers.

Research Plan

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms,
and Genome Wide Association Studies (GWAS)) as provided in the PHS398
Application Guide.

EPA Human Subjects Research
Statement (HSRS) (4 pages)

All human research studies conducted or supported by EPA are
governed by EPA regulations at 40 CFR Part 26 (Protection of Human Subjects; http://www.gpo.gov/fdsys/pkg/CFR-2010-title40-vol1/xml/CFR-2010-title40-vol1-part26.xml).
This includes the Basic Federal Policy for the Protection of Human Research
Subjects, also known as the Common Rule, at subpart A and additional
prohibitions and special protections for pregnant women, nursing women, and
children in research conducted or supported by EPA at subparts B, C, and D.
Depending upon the type of research being conducted, additional subparts of 40
CFR 26 may be relevant.

Procedures for the review and oversight of human research
subject to 40 CFR Part 26 are also provided in EPA Order 1000.17 Change A1 (http://www.epa.gov/phre/pdf/epa_order_1000-17-a1.pdf).
These include review of projects for EPA-supported human research by the EPA
Human Subjects Research Review Official (HSRRO). EPA Order 1000.17 Change A1
requires preliminary approval by the HSRRO of all proposed EPA-supported human
research before the agreement can be entered into. Additional requirements
must be met and final approval received from the HSRRO before the research can
begin. When reviewing human observational exposure studies, EPA Order 1000.17
Change A1 requires the HSRRO to apply the principles described in the SEAOES
document (http://www.epa.gov/nerl/sots/SEAOES_doc20080707.pdf)
and grant approval only to studies that adhere to those principles.

All applications submitted under this solicitation must
include a HSRS as described below. Use the definitions below to determine
whether the proposed research involves human subjects, and then prepare a HSRS
as explained below in the “HSRS Requirements” section.

Definitions (from 40 CFR 26 Subparts A, B, and C)

"Human subject" means a living individual about whom an
investigator (whether professional or student) conducting research obtains (1)
data through intervention or interaction with the individual, or (2)
identifiable private information.

"Intervention" includes both physical procedures by
which data are gathered (for example, venipuncture) and manipulations of the
subject or the subject's environment that are performed for research purposes.

"Interaction" includes communication or interpersonal
contact between investigator and subject.

"Private information" includes information about
behavior that occurs in a context in which an individual can reasonably expect
that no observation or recording is taking place, and information which has
been provided for specific purposes by an individual and which the individual
can reasonably expect will not be made public (for example, a medical record).

"Individually identifiable" means the identity of the
subject is or may readily be ascertained by the investigator or associated with
the information.

"Research involving the intentional exposure of a human
subject" means a study of a substance in which the exposure to the
substance experienced by a human subject participating in the study would not
have occurred but for the human subject’s participation in the study.

"Observational research" means any human research that
does not meet the definition of research involving intentional exposure of a
human subject.

Human Subjects Research Statement (HSRS) Requirements

If the proposed research does not involve human subjects as
defined above, provide the following statement in your application package as
your HSRS: “The proposed research does not involve human subjects.” Applicants
should provide a clear justification about how the proposed research does not
meet the definition (for example, all samples come from deceased individuals OR
samples are purchased from a commercial source and provided without
identifiers, etc).

If the proposed research involves human subjects, then
include in your application package a HSRS that addresses each applicable
section listed below, referencing the specific location of the information in
the Research Plan, providing the information in the HSRS, or explaining why the
section does not apply to the proposed research. (Not all will apply.) Please
use the definitions provided above to ensure consistency in the interpretation
of terminology. Do not exceed four consecutively numbered, 8.5x11-inch pages
of single-spaced, standard 12-point type with 1-inch margins.

NOTE: Before EPA approves any research involving human
subjects, the requirements of the regulations at 40 CFR 26 must be met. For
further information, see Section VI.C.3. Also, before EPA approves human
observational exposure research, EPA will examine it to ensure consistency with
the SEAOES Principles. The factors below are not intended to be exhaustive of
all those needed for the HSRRO to provide the final approval necessary for
research to be conducted, but provide a basis upon which the HSRRO may grant
the conditional approval necessary for the funding process to begin.

(1) Human subjects involvement, characteristics, and
design.

(a) Describe and justify the proposed involvement of
human subjects in the work being proposed.

(b) Describe the characteristics of the subject
population, including their anticipated number, page range, and health status
if relevant.

(c) Describe and justify the sampling plan, as well
as the recruitment and retention strategies and the criteria for inclusion or
exclusion of any subpopulations.

(d) Describe the research material that will be
obtained from or about living individuals in the form of data,
specimens, or records.

(e) List any collaborating sites where human subjects
research will be performed, and describe the role of those sites and
collaborating investigators in the research.

(f) Describe and justify any compensation being
provided to subjects for their participation in the research.

(g) Describe the plan for communicating individual
and/or aggregate research results to participants, if relevant.

(2) Potential risks to subjects.

(a) Describe the potential risks to human subjects
(physical, psychological, financial, legal, or other) and assess their
likelihood and seriousness to the human subjects.

(3) Adequacy of protection against risks.

(a) Describe planned procedures for protecting
against or minimizing potential risks and assess their likely effectiveness.

(b) Describe planned procedures for the process of
obtaining and maintaining informed consent. Include a description of the
circumstances under which consent will be sought and obtained, who will seek
it, the nature of the information to be provided to prospective subjects, and
the method of documenting consent.

(c) If waiver of some or all of the elements of
informed consent or of documentation of consent will be sought, provide
justification for the waiver.

(d) Where appropriate, discuss the plans for ensuring
necessary medical or professional intervention in the event of adverse effects
to subjects.

(4) Protection of vulnerable groups.

(a) Explain the rationale for the involvement of any
vulnerable populations, including pregnant women, fetuses, and children if relevant.

(b) Describe the additional protections in place, if
any, for protecting vulnerable populations included in the research.

(c) If children are included in the research,
describe the process for obtaining parental permission and child assent if
relevant.

(5) Protection of privacy and confidentiality.

(a) Describe how data, specimens, and/or records will
be collected, managed, and protected, including at collaborating sites, if any,
as well as at the primary site.

(b) Indicate who will have access to individually
identifiable private information about human subjects.

(c) Describe any additional procedures for the
protection of privacy and confidentiality of the human research subjects.

(d) Discuss any mandatory reporting requirements with
the potential to come into play during the conduct of the research and describe
how these will be communicated to participants if relevant.

(e) Discuss the potential of the research to obtain
information about third parties and describe how this will be handled if it occurs.

(6) Relationship between researcher and community.

(a) If the research will take place in a community
setting, describe the procedures in place for defining the community, obtaining
its involvement in the research, and establishing and maintaining trust.

(7) Potential benefits of the research to the participants
and others.

(a) Discuss the potential benefits of the research to
the research participants and others.

(b) Discuss why the risks to subjects are reasonable
in relation to the anticipated benefits.

(8) Importance of the knowledge to be gained.

(a) Discuss the importance of the knowledge to be
gained as a result of the proposed research.

(b) Discuss why the risks to subjects are reasonable
in relation to the importance of the knowledge that reasonably may be expected
to result.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS398 Application Guide.

For EPA awards: Executive Order 12372, “Intergovernmental
Review of Federal Programs,” does not apply to the EPA’s Office of Research and
Development's research and training programs unless EPA has determined that the
activities that will be carried out under the application (a) require an
Environmental Impact Statement (EIS), or (b) do not require an EIS but will be
newly initiated at a particular site and require unusual measures to limit the
possibility of adverse exposure or hazard to the general public, or (c) have a unique
geographic focus and are directly relevant to the governmental responsibilities
of a State or local government within that geographic area.

If EPA determines that Executive Order 12372 applies to an application,
the applicant must follow the procedures in 40 CFR Part 29. The applicant must
notify their state's single point of contact (SPOC). To determine whether their
state participates in this process, and how to comply, applicants should
consult http://www.whitehouse.gov/omb/grants_spoc/.
If an applicant is in a State that does not have a SPOC, or the State has not
selected research and development grants for intergovernmental review, the
applicant must notify directly affected State, area wide, regional and local
entities of its application.

EPA will notify the successful applicant(s) if Executive
Order 12372 applies to its application prior to award.

EPA awards are subject to the following funding
restrictions:

EPA awards funds to one eligible applicant as the recipient
even if other eligible applicants are named as partners or co-applicants or
members of a coalition or consortium. The recipient is accountable to EPA for
the proper expenditure of funds. IF the grant is funded by both NIEHS and EPA,
then the recipient is accountable to EPA and NIEHS for the proper expenditure
of funds.

All award decisions are subject to the availability of
funds. In accordance with the Federal Grant and Cooperative Agreement Act, 31
U.S.C. 6301 et seq., the primary purpose of an assistance agreement is to
accomplish a public purpose of support or stimulation authorized by federal
statute, rather than acquisition for the direct benefit or use of the Agency.
In issuing a grant, the EPA and NIEHS anticipate that there will be no
substantial EPA involvement in the design, implementation, or conduct of the
research. However, the EPA and NIEHS will monitor research progress through a
variety of means, including annual reports provided by grantees and other
contacts, as well as site visits with the Principal Investigator(s).

EPA funding may be used to provide subgrants or subawards of
financial assistance, which includes using subawards or subgrants to fund
partnerships, provided the recipient complies with applicable requirements for
subawards or subgrants including those contained in 40 CFR Parts 30 or 31, as
appropriate. Applicants must compete contracts for services and products,
including consultant contracts, and conduct cost and price analyses to the
extent required by the procurement provisions of the regulations at 40 CFR
Parts 30 or 31, as appropriate. The regulations also contain limitations on
consultant compensation. Applicants are not required to identify
subawardees/subgrantees and/or contractors (including consultants) in their
application. However, if they do, the fact that an applicant selected for
award has named a specific subawardee/subgrantee, contractor, or consultant in
the application EPA selects for funding does not relieve the applicant of its
obligations to comply with subaward/subgrant and/or competitive procurement
requirements as appropriate. Please note that applicants may not award sole
source contracts to consulting, engineering or other firms assisting applicants
with the application based solely on the firm's role in preparing the application.

Successful applicants cannot use subgrants or subawards to
avoid requirements in EPA grant regulations for competitive procurement by
using these instruments to acquire commercial services or products from
for-profit organizations to carry out its assistance agreement. The nature of
the transaction between the recipient and the subawardee or subgrantee must be
consistent with the standards for distinguishing between vendor transactions
and subrecipient assistance under Subpart B Section .210 of OMB Circular A-133,
and the definitions of subaward at 40 CFR 30.2(ff) or subgrant at 40 CFR 31.3,
as applicable. Neither EPA nor NIEHS will be a party to these transactions.
Applicants acquiring commercial goods or services must comply with the
competitive procurement standards in 40 CFR Part 30 or 40 CFR Part 31.36 and
cannot use a subaward/subgrant as the funding mechanism.

Section V of the announcement describes the evaluation
criteria and evaluation process that will be used to make selections under this
announcement. During this evaluation, except for those criteria that relate to
the applicant's own qualifications, past performance, and reporting history,
the review panel will consider, if appropriate and relevant, the
qualifications, expertise, and experience of:

(i) an applicant's named subawardees/subgrantees identified
in the application if the applicant demonstrates in the application that if it
receives an award that the subaward/subgrant will be properly awarded
consistent with the applicable regulations in 40 CFR Parts 30 or 31. For
example, applicants must not use subawards/subgrants to obtain commercial
services or products from for profit firms or individual consultants.

(ii) an applicant's named contractor(s), including
consultants, identified in the application if the applicant demonstrates in its
application that the contractor(s) was selected in compliance with the
competitive procurement standards in 40 CFR Part 30 or 40 CFR 31.36 as
appropriate. For example, an applicant must demonstrate that it selected the
contractor(s) competitively or that a proper non-competitive sole-source award
consistent with the regulations will be made to the contractor(s), that efforts
were made to provide small and disadvantaged businesses with opportunities to
compete, and that some form of cost or price analysis was conducted. EPA may
not accept sole source justifications for contracts for services or products
that are otherwise readily available in the commercial marketplace.

As part of the budgetary process, EPA will not consider the
qualifications, experience, and expertise of named subawardees/subgrantees
and/or named contractor(s) during the application evaluation process unless the
applicant complies with these requirements.

Each proposed project must be able to be completed within
the project period and with the initial award of funds. Applicants should
request the entire amount of money needed to complete the project. Recipients
should not anticipate additional funding beyond the initial award of funds for
a specific project.

6. Other Submission Requirements and
Information

Applications must be received on the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

Budget for Submissions to EPA: Please note that when
formulating budgets for proposals/applications, applicants must not include
management fees or similar charges in excess of the direct costs and indirect
costs at the rate approved by the applicants cognizant audit agency, or at the
rate provided for by the terms of the agreement negotiated with EPA. The term
"management fees or similar charges" refers to expenses added to the
direct costs in order to accumulate and reserve funds for ongoing business expenses,
unforeseen liabilities, or for other similar costs that are not allowable under
EPA assistance agreements. Management fees or similar charges may not be used
to improve or expand the project funded under this agreement, except to the
extent authorized as a direct cost of carrying out the scope of work.

Confidentiality:

By submitting an application in response to this Funding
Opportunity Anncouncement, the applicant grants the EPA permission to make
limited disclosures of the application to technical reviewers both within and
outside the Agency for the express purpose of assisting the Agency with
evaluating the application. Information from a pending or unsuccessful
application will be kept confidential to the fullest extent allowed under law;
information from a successful application may be publicly disclosed to the
extent permitted by law.

EPA recommends that you do not include confidential business
information (“CBI”) in your application. However, if confidential business
information is included, it will be treated in accordance with 40 CFR 2.203.
Applicants must clearly indicate which portion(s) of their proposal/application
they are claiming as CBI. EPA will evaluate such claims in accordance with 40
CFR Part 2. If no claim of confidentiality is made, EPA is not required to
make the inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2)
prior to disclosure. The Agency protects competitive proposals/applications
from disclosure under applicable provisions of the Freedom of Information Act
prior to the completion of the competitive selection process.

NIEHS and EPA awards:

Each Center must budget $5,000.00 per year to support annual
Children's Environmental Health Meetings in venues yet to be determined in
collaboration with the Center Investigators, NIEHS and EPA Program Officials.
These funds can be used to support costs asociated with logistics of the annual
Children's Center meeting, including facilities necessary for hosting meeting
and traveling outside speakers. Additionally, Centers will be responsible for
the support of traveling key personnel to the annual Children's Center
Meetings. All Program Directors will be expected to be an active participant
in the planning and implementation of the annual meeting.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115, with the following modifications:

EPA Award Procedures: Applicants to be recommended for EPA
funding will be required to submit additional information and an electronic
version of the revised project abstract. They may also be asked to
provide responses to comments or suggestions offered by the peer reviewers
and/or a revised budget. EPA Project Officers will contact the Principal
Investigator to obtain these materials. Before or after an award,
applicants may be required to provide additional quality assurance
documentation.

EPA Quality Assurance Documentation: For any project
involving data collection or processing, conducting surveys, environmental
measurements, modeling, or the development of environmental technology (whether
hardware-based or via new techniques), EPA will require the recipient to submit
a Quality Management Plan and other appropriate quality assurance documentation
on the processes that will be used to assure that results of the research
satisfy the intended project objectives. This is not required for application submission,
but will be required for any applications that EPA chooses to recommend for
funding. More detailed information on requirements can be found at http://www.epa.gov/ncer/guidance/qa.html.

Section
V. Application Review Information

1. Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of
the following review criteria and additional review criteria (as applicable for
the project proposed).

Does the Center consist of
a cohesive and multidisciplinary focus? Does a coordinated interrelationship
exist between the research projects and cores? Are the components of the
Center related to the common theme of the Center? What is the scientific gain
of combining the component parts into a Center? For new applications, is there
evidence of the degree of synergy (degree of interaction, collaborative
research opportunities) that will be stimulated by the Center? How do the
research projects and cores relate to the central theme and the ability of the
Center to meet its long range goals? Will the specific scientific objectives of
each project benefit significantly from, or depend upon collaborative
interactions with other projects in the program (i.e., objectives that can be
uniquely accomplished, specific contributions to the accomplishments of
objectives in other projects, objectives that can be accomplished with greater
effectiveness and/or economy of effort)? Have the investigators adequately
conceptualized the Center’s expected results and potential benefits to the
broader public?

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD(s)/PI(s), do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will not
give separate scores for these items.

If
the Research Project(s) include(s) Community Based Participatory Research as an
aspect of the Project, then the following criteria will be included in the
evaluation. Are the Center’s
activities appropriate to the needs of the community involved? Is the research
proposed focused on children’s environmental health or the exposure under
investigation? Is there a mechanism present for regular communication and
coordination among investigators and relevant stakeholders with concerns
focused on children’s environmental health or environmental exposures? Are the
stakeholders involved in other aspects of the Center? Does a productive
working relationship exist between Center investigators and community
stakeholders? Will information be adequately disseminated?

Administrative Core

What is the
decision-making process within the proposed Center? Is it adequate for the
evaluation of research productivity, allocation of funds, and management of the
resources? Are procedures clearly outlined to measure and track Center goals,
outputs and outcomes?

How will the
Administrative Core promote joint planning and evaluation activities as well as
collaborations and interactions among different Research Projects of the Centers?

What are the academic
environment and resources in which the research will be conducted? Is there
available and appropriate space, equipment, human subjects, animals, or other
resources as required for potential interaction with scientist(s) from other
departments to complete the scope of work as proposed?

What is the institutional
commitment to the Center, including fiscal responsibility and management
capability of the institution to assist the PD/PI and his/her staff in
following DHHS, PHS, NIH and EPA policy?

If the community
engagement is discussed as a function of the Administrative Core, then the
following criteria must be included in the evaluation. Are the Center’s
activities appropriate to the needs of the community involved? How will the Center
facilitate regular communication and coordination among investigators and
relevant stakeholders with concerns focused on children’s environmental health
or environmental exposures? How are the stakeholders involved in other aspects
of the Center and how they will interact with Center activities and develop a
relationship with the Center Investigators? If a Community Advisory Board
is proposed, does it have appropriate and adequate membership to be successful?

Facility/Service Cores

What is the Core's
utility to Center investigators? Does each Core provide services for two or
more research projects that are judged to have substantial merit?

What is the quality of
the facility or services provided?

What are the availability
and/or adequacy of the physical space, laboratory, clinic and/or equipment
proposed for the Core?

What is the
cost-effectiveness of the service provided?

Are the qualifications of
the personnel involved, their experience, and commitment to the Core
appropriate?

Community Outreach and Translation Core

Are the plans for the
establishment of a Community Outreach and Translation Core appropriate and
adequate for success?

Have particular community
groups or organizations been identified and are their support and commitment
adequate and appropriate?

Are the detailed plans
and approaches for dissemination from the Core adequate for success?

Protections
for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of
minorities and members of both genders, as well as the inclusion of children. For
additional information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Applicable.

Additional Review Considerations – Overall

As applicable for the project proposed,
reviewers will consider each of the following items, but will not give scores
for these items, and should not consider them in providing an overall
impact/priority score.

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider
whether the budget and the requested period of support are fully justified and
reasonable in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s)convened by NIEHS in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall
impact/priority score.

Applications will be assigned to NIEHS and will compete for
available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive
a second level of review by the National Advisory Environmental Health Sciences
Council. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

EPA Selection Process Post Review:

EPA's internal review criteria for all applications under
consideration for EPA support:

Applications discussed and receiving numerical impact/priorty
scores as a result of the NIEHS peer review will undergo an internal
programmatic review, as described below, conducted by technical experts from
the EPA, including individuals from the Office of Research and Development
(ORD) and program and regional offices involved with the science or engineering
proposed. All other applications are automatically declined.

After the peer review, those applicants receiving numerical impact/priority
scores will be asked to provide additional information for the programmatic
review pertaining to the proposed Principal Investigator's (PI) (in the case of
Multiple-PI applications, the Contact PI’s) "Past Performance and
Reporting History." The applicant must provide the EPA Project Officer
with information on the proposed Contact PI's past performance and reporting
history under prior Federal agency assistance agreements (assistance agreements
include grants and cooperative agreements but not contracts) in terms of: (i)
the level of success in managing and completing each agreement, and (ii)
history of meeting the reporting requirements under each agreement.

This information is required only for the proposed Contact
PI's performance under Federal assistance agreements initiated within the last
three years that were similar in size and scope to the proposed project.

The specific information required for each agreement is
shown below, and must be provided within three weeks of EPA's request. A
maximum of three pages will be permitted for the response; excess pages will
not be reviewed. Note: If no prior past performance information and/or
reporting history exists, you will be asked to so state.

1. Name of Granting Agency.

2. Grant number.

3. Grant title.

4. Brief description of the grant.

5. A description of how the agreement is similar in
size and scope to the proposed project and whether or not it was successfully
managed and completed; if not successfully managed and completed, provide an
explanation.

6. Information relating to the proposed /Contact
PI's past performance in reporting on progress towards achieving the expected
results (outputs/outcomes) under the agreement. Include the history of
submitting timely progress/final technical reports, describe how progress
towards achieving the expected results was reported/documented, and if such
progress was not being made, provide an explanation of whether, and how, this
was reported.

The purpose of the programmatic review is to ensure an
integrated research portfolio for the Agency and help determine which
applications to recommend for award. In conducting the programmatic review,
the EPA will consider information provided by the applicant and may consider
information from other sources, including prior and current grantors and agency
files.

The EPA internal programmatic review panel will assess:

1. The relevance of the proposed science to EPA
research priorities.

2. The proposed Contact PI's past performance [under
Federal agency assistance agreements (assistance agreements include grants and
cooperative agreements but not contracts) initiated within the last three years
that were similar in size and scope to the proposed project] in two areas:
First, in successfully managing and completing these prior Federal assistance
projects, including whether there is a satisfactory explanation for any lack of
success. Second, in reporting progress toward achieving results under these
agreements, including the proposed Contact PI's history of submitting timely
progress/final technical reports that adequately describe the progress toward
achieving the expected results (outputs/outcomes) under the agreements. Any
explanation of why progress toward achieving the results was not made will also
be considered. Applicants whose proposed Contact PI has no relevant past
performance and/or reporting history, or for whom this information is not
available, will be evaluated neither favorably nor unfavorably on these
elements.

EPA considers relevance more important than the Contact PI’s
past performance.

EPA Human Subjects Research
Statement (HSRS) Review

Applications being
considered for funding after the EPA Programmatic Review that involve human
subjects research studies will have their HSRS reviewed by EPA’s Human Subjects
Research Review Official (HSRRO) prior to award. The HSRRO will review the
information provided in the HSRS and the Research Plan to determine if the
ethical treatment of human subjects is described in a manner appropriate for
conditional approval to be granted.

Final EPA funding decisions
are made by the NCER Director based on the results of the peer review, the
internal programmatic review and, where applicable, the EPA HSRRO’s assessment
of the applicant’s HSRS (see Section IV). In addition, in making the final
funding decisions, the NCER Director may also consider program balance and
available funds. Applicants selected for funding will be required to provide
additional information listed below under “Award Notices.” The application will
then be forwarded to EPA’s Grants and Interagency Agreement Management Division
for award in accordance with the EPA’s procedures.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

For EPA, the official notification of an award will be made
by the Agency’s Grants and Interagency Agreement Management Division.
Applicants are cautioned that only a grants officer is authorized to bind the
Government to the expenditure of funds; preliminary selection by the NCER
Director in the Office of Research and Development does not guarantee an award
will be made.

Non-profit applicants that are recommended for EPA funding
under this announcement are subject to pre-award administrative capability
reviews consistent with Sections 8b., 8c. and 9d. of EPA Order 5700.8 - Policy
on Assessing Capabilities of Non-Profit Applicants for Managing Assistance
Awards (http://www.epa.gov/ogd/grants/award/5700_8.pdf).
In addition, non-profit applicants that qualify for funding may, depending on
the size of the award, be required to fill out and submit to the Grants
Management Office the Administrative Capabilities Form with supporting
documents contained in Appendix A of EPA Order 5700.8.

Disputes related to this assistance agreement competition
will be resolved in accordance with the dispute resolution procedures set forth
in 70 FR 3629, 3630 (January 26, 2005) which can be found at http://www.epa.gov/ogd/competition/resolution.htm.
Questions regarding disputes may be referred to the Eligibility Contact
identified below.

Expectations and responsibilities of EPA/NCER grantees are
summarized in this section, although the terms grant and grantee are used. See http://www.epa.gov/ncer/guidance for the full terms and conditions associated with an award, including which
activities require prior approval from the EPA.

a. Meetings: Principal Investigators will be expected to
budget for, and participate in, All-Investigators Meetings (also known as
progress reviews) approximately once per year with EPA and NIEHS scientists and
other grantees to report on research activities and discuss issues of mutual
interest.

b. Approval of Changes after Award: Prior written approval
of changes may be required from EPA. Examples of these changes are contained in
40 C.F.R. 30.25. Note: prior written approval is also required from the EPA
Award Official for incurring costs more than 90 calendar days prior to award.

c. Human Subjects: A grant applicant must agree to meet all
EPA requirements for studies using human subjects prior to implementing any
work with these subjects. These requirements are given in 40 CFR § 26.
Studies involving intentional exposure of human subjects who are children or
pregnant or nursing women are prohibited by Subpart B of 40 CFR § 26. For
observational studies involving children or pregnant women and fetuses please
refer to Subparts C & D of 40 CFR § 26. U.S. Department of Health and
Human Services regulations at 45 CFR § 46.101(e) have long required "...
compliance with pertinent Federal laws or regulations which provide additional
protection for human subjects." EPA’s regulation 40 CFR § 26 is such a
pertinent Federal regulation. Therefore, the applicant's Institutional Review
Board (IRB) approval must state that the applicant's study meets the EPA's
regulations at 40 CFR § 26. No work involving human subjects, including
recruiting, may be initiated before the EPA has received a copy of the
applicant’s IRB approval of the project and the EPA has also provided approval.
Where human subjects are involved in the research, the recipient must provide
evidence of subsequent IRB reviews, including amendments or minor changes of
protocol, as part of annual reports.

d. Animal Welfare: A grant recipient must agree to comply with
the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 U.S.C. 2131-2156.
The recipient must also agree to abide by the "U.S. Government Principles
for the Utilization and Care of Vertebrate Animals used in Testing, Research,
and Training" (50 Federal Register 20864-20865. May 20, 1985).

e. Congress, through OMB, has instructed each federal agency
to implement Information Quality Guidelines designed to "provide policy
and procedural guidance...for ensuring and maximizing the quality, objectivity,
utility, and integrity of information, including statistical information,
disseminated by Federal agencies." The EPA's implementation may be found
at http://epa.gov/quality/exmural.html#genreqts.
These procedures may apply to data generated by grant recipients if those data
are disseminated as described in the Guidelines.

The Office of Management and Budget (OMB) Circular A-110
located at 2 CFR Part 215 has been revised to provide public access to research
data through the Freedom of Information Act (FOIA) under some circumstances.
Data that are (1) first produced in a project that is supported in whole or in
part with federal funds and (2) cited publicly and officially by a federal
agency in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. If such data are requested by the
public, the EPA must ask for it, and the grantee must submit it, in accordance
with A-110 and the EPA regulations at 40 C.F.R. 30.36.

NIH grants policies as described in the NIH Grants
Policy Statement and the Grants Compliance
and Oversight section will apply to the applications submitted and awards
made in response to this FOA. Recipients of NIH and EPA grant funds must
comply with all applicable Federal statutes (such as those included in
appropriations acts) regulations, and policies. Additionally, they must also
comply with their institutional requirements.

EPA Reporting Requirements

An EPA grant recipient is expected to manage assistance
agreement funds efficiently and effectively and make sufficient progress towards
completing the project activities described in the research plan in a timely
manner. The assistance agreement will include terms/conditions implementing
this requirement.

A grant recipient must agree to provide annual progress
reports, with associated summaries, and a final report with an executive
summary. The executive summary will be posted on EPA/NCER’s website.

A grant recipient must agree to provide copies of any peer
reviewed journal article(s) resulting from the research during the project period.
In addition, the recipient should notify the EPA Project Officer of any papers
published after completion of the grant that were based on research supported
by the grant. NCER posts references to all publications resulting from a grant
on the NCER web site.

Acknowledgement of EPA Support: EPA’s full or partial
support must be acknowledged in journal articles, oral or poster presentations,
news releases, interviews with reporters and other communications. Any
documents developed under this agreement that are intended for distribution to
the public or inclusion in a scientific, technical, or other journal shall
include the following statement or another as specified by EPA’s project
officer:

This publication [article] was made possible by EPA grant
number _______. Its contents are solely the responsibility of the grantee and
do not necessarily represent the official views of the EPA. Further, the EPA
does not endorse the purchase of any commercial products or services mentioned
in the publication.

Subaward and Executive Compensation Reporting: Applicants
must ensure that they have the necessary processes and systems in place to
comply with the sub-award and executive total compensation reporting
requirements established under OMB guidance at 2
CFR Part 170, unless they qualify for an exception from the requirements,
should they be selected for funding.

1. Be registered in the CCR prior to submitting an
application or proposal under this announcement. CCR information can be found
at https://www.bpn.gov/ccr/

2. Maintain an active CCR registration with current
information at all times during which it has an active Federal award or an
application or proposal under consideration by an agency, and

3. Provide its DUNS number in each application or proposal
it submits to the agency. Applicants can receive a DUNS number, at no cost,
by calling the dedicated toll-free DUNS Number request line at 1-866-705-5711,
or visiting the D&B website at: http://www.dnb.com.

If an applicant fails to comply with these requirements, it
will, should it be selected for award, affect their ability to receive the
award.

EPA Pre-Application Assistance and Communications: In
accordance with EPA's Assistance Agreement Competition Policy (EPA Order
5700.5A1), EPA staff will not meet with individual applicants to discuss draft
proposals, provide informal comments on draft proposals, or provide advice to
applicants on how to respond to ranking criteria. Applicants are responsible
for the contents of their applications/proposals. However, consistent with the
provisions in the announcement, EPA will respond to questions from individual
applicants regarding threshold eligibility criteria, administrative issues
related to the submission of the proposal, and requests for clarification about
the announcement. In addition, if necessary, EPA may clarify threshold
eligibility issues with applicants prior to making an eligibility determination.

Website References in FOA: Any non-federal websites or
website links included in this FOA are provided for proposal preparation and/or
informational purposes only. U.S. EPA does not endorse any of these entities
or their services. In addition, EPA does not guarantee that any linked,
external websites referenced in this FOA comply with Section 508 (Accessibility
Requirements) of the Rehabilitation Act.

Unpaid Federal Tax Liabilities and Felony Convictions for
Non-Profit and For-Profit Organizations: EPA Awards made under this
announcement are subject to the provisions contained in the Department of
Interior, Environment, and Related Agencies Appropriations Act, 2012, HR 2055,
Division E, Sections 433 and 434 regarding unpaid federal tax liabilities and
federal felony convictions. These provisions prohibit EPA from awarding funds
made available by the Act to any for-profit or non-profit organization: (1)
subject to any unpaid Federal tax liability that has been assessed, for which
all judicial and administrative remedies have been exhausted or have lapsed,
and that is not being paid in a timely manner pursuant to an agreement with the
authority responsible for collecting the tax liability; or (2) that was
convicted (or had an officer or agent of such corporation acting on its behalf
convicted) of a felony criminal conviction under any Federal law within 24
months preceding the award, unless EPA has considered suspension or debarment
of the corporation, or such officer or agent, based on these tax liabilities or
convictions, and determined that such action is not necessary to protect the
Government's interests. Non-profit or for-profit organizations that are
covered by these prohibitions are ineligible to receive an award under this
announcement.

Exchange Network: EPA, states, territories, and tribes are
working together to develop the National Environmental Information Exchange
Network, a secure, Internet- and standards-based way to support electronic data
reporting, sharing, and integration of both regulatory and non-regulatory
environmental data. States, tribes and territories exchanging data with each
other or with EPA, should make the Exchange Network and the Agency's connection
to it, the Central Data Exchange (CDX), the standard way they exchange data and
should phase out any legacy methods they have been using. More information on
the Exchange Network is available at www.exchangenetwork.net.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

The EPA authority for this FOA and resulting awards is
contained in the Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1; the
Toxic Substances Control Act, Section 10, 15 U.S.C. 2609; the Federal
Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r; the
Clean Air Act, Section 103, 42 U.S.C. 7403; the Clean Water Act, Section 104,
33 U.S.C. 1254; and the Solid Waste Disposal Act, Section 8001, 42 U.S.C. 6981.
For research with an international aspect, the above statutes are supplemented,
as appropriate, by the National Environmental Policy Act, Section 102(2)(F).